(55 days)
No
The summary describes a modified bite block designed to accommodate an oral nasal cannula for gas sampling and oxygen delivery during endoscopy. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No
The device is described as an endoscopy accessory, specifically a bite block, designed to facilitate the use of an oral nasal cannula during procedures. Its primary function is mechanical support and access, not direct therapeutic action on a disease or condition.
No
The device is a bite block accessory used during endoscopy procedures to facilitate capnography and oxygen administration. It does not perform diagnostic functions itself, but rather supports the use of another device (capnograph) that performs diagnostic measurements.
No
The device description clearly identifies the device as a "Bite Block," which is a physical, hardware accessory used during endoscopy procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided text, the Smart BiteBloc™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used during endoscopy procedures to facilitate the use of an oral nasal cannula for collecting breathing samples and administering oxygen. It's a physical accessory used in vivo (on the patient) during a medical procedure.
- Device Description: It's described as an endoscopy accessory, specifically a modified bite block. Bite blocks are physical devices used to protect the patient's mouth and the endoscope.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Reagents, calibrators, or controls.
The device's function is to physically support and enable the use of another device (the oral nasal cannula) which then collects samples for analysis by a separate device (the capnograph). The Smart BiteBloc™ itself does not perform any diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).
Product codes
CCK, MNK
Device Description
Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
non intubated patients who weigh more than 55 lbs (25 kg).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K954352, K924304, K896691, K915816, K931044, K914978
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
NOV 2 3 20 2. Modified 510(k) Summarv
To Incorporate Bite Block Classification and Product Code
7.0 510(k) Summary of Safety and Effectiveness Information (This document is not confidential)
PRODUCT NAME
Proprietary: Smart BiteBloc TM
Common: Bite Lock Endoscopy/Capnography Accessory
ESTABLISHMENT REGISTRATION NUMBER
Establishment Registration Number: 3003941644
ESTABLISHMENT ADDRESS:
Oridion Capnography Inc.
21 Highland Circle
Needham, MA 02494-3038
CONTACT PERSON:
Sanford Brown, Regulatory Affairs Director
Oridion Medical 1987 Ltd.
Har Hotzvim Science Based Industrial Park
POB 45025
91450 Jerusalem, Israel
Telephone: +972-2-589-9115
FAX: +972-2-586-6680
DEVICE LISTING FDA FORM 2892:
B051971
1
DEVICE DESCRIPTION
Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.
SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Devices
United States Endoscopy K954352
United States Endoscopy K924304
Endoscopix Bite Block K896691
Gl Supply Bite Block K915816
GI Supply Oxy-Block K931044
Stantex Pty Ltd Oxiguard K914978
The Smart BiteBloc™ has the same intended use as the predicate devices identified in this section. Any technological differences with the predicate devices do not raise any new questions regarding safety and effectiveness. Therefore, Oridion considers the Smart BiteBloc to be substantially equivalent to the predicate devices.
PRODUCT CLASSIFICATION
73CCK Class II
21 CFR 868.1400, carbon dioxide analyzer
The BiteBloc™ itself is normally classified according to 21CFR876.1500 as follows:
Class I
Product Code MNK
INTENDED USE
The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Mr. Sandy Brown Regulatory Affairs Director Oridion Medical 1987 Limited 7 Hamarpe Street Jerusalem, 91450 ISRAEL
Re: K042665
Trade/Device Name: BiteBlocTM Regulation Number: 868.1400 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCK, MNK Dated: September 27, 2004 Received: September 29, 2004
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Culs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Supplementary Submission BiteBlock K042665 Reply to FDA Questions of November 5, 2004 Modified Indications for Use Statement
2. Modified Indications for Use Statement
This document is not confidential
November 11, 2004
Device Name:
BiteBloc™
Indications For Use:
The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Acee Sullivans
(Division of Anesthesiology, General Hospital, Infection Control, De
510(k) Number:_
OR